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510(k) Data Aggregation

    K Number
    K990724
    Device Name
    CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES
    Manufacturer
    CONWAY STUART MEDICAL, INC.
    Date Cleared
    1999-08-13

    (161 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CONWAY STUART MODEL 100 IRRIGATION PUMP & ACCESSORIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Conway Stuart Medical Model 100 Irrigation Pump and Accessories is indicated for irrigation of tissue.

    Device Description

    Model 100 Irrigation Pump and Accessories

    AI/ML Overview

    This document is a 510(k) premarket notification decision letter from the FDA for the Conway Stuart Medical Model 100 Irrigation Pump and Accessories. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

    The letter merely states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and therefore allows Conway Stuart Medical, Inc. to market the device.

    Therefore, I cannot extract the requested information from the provided text.

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